CBBS: If electronic images of testing instrumentation data are validated to show that the data is identical to those of hard-copy printouts from the instrument, would a facility be required to keep the printouts from the instrument?

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If electronic images of testing instrumentation data are validated to show that the data is identical to those of hard-copy printouts from the instrument, would a facility be required to keep the printouts from the instrument?

The above question was submitted to the "Ask the FDA" session at the 2003 AABB meeting in San Diego.

According to Kay R. Gregory MS MT(ASCP)SBB, Director Regulatory Affairs AABB (attribution used with permission), Alan Williams, PhD, Director, Division of Blood Applications has asked AABB to clarify his response to this question on Nov. 3, 2003.

Dr Williams' answer (posted in the Fastbreaking News section on Nov. 20) is no, it is not necessary to keep the printouts from the instrument, if there is validation performed to show that the electronic format is identical and regularly accessible as needed.

Since the e-Network Forum has received a comment from a California coilleague on this issue, we are opening it for further discussion here.

ADDENDA Dec. 9, 2003

1. A colleague who is very familiar with the rules, regulations and laws governing transfusion service laboratories in California is of the opinion that validation of electronic copies must meet all of the requirements addressing an audit trail and documented proof that any particular electronic record has captured the original data stream and contains original, unaltered information. Furthermore, if a report must be altered, there must be sufficient detail to verify the alteration has occurred, including the date, time, personnel, original results, altered results, etc. This opinion is given with the caveat that Final Interpretive Guidelines for the CLIA FINAL RULE are not yet available, but will be soon.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

Posted: December 9, 2003

Addenda:

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